MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETLW1616C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.The patient had pre-existing distal aortic narrowing with calcification.It was reported that the patient presented one week post the index procedure with leg pain, and an occluded limb was identified on ct scan.A thrombectomy with ivus and pta was carried out to resolve the occlusion.As per the physician, the cause of the event was due to the patients narrow calcified distal aorta.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the caused of the reported limb occlusion seen one week post-implant could not be determined from the pre-implant films provided.Images during implant and post-implant were not available for review and the reported occlusion and stent graft in-vivo configuration could not be assessed.The location/side of the occlusion was also not reported.It is possible that implanting within the severely calcified and small caliber distal aorta may have led to limb compression and resulting occlusion.Other possible occlusion contributors (which are currently unknown) include limb/vessel oversizing, and if the occluded limb may have been extended into the external iliac artery.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9004051
• Report Number: 9612164-2019-03879
• Device Sequence Number: 2377012
• Product Code: MIH
• UDI-Device Identifier: 00643169467668
• UDI-Public: 00643169467668
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: ETLW1616C156E
• Device Catalogue Number: ETLW1616C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR